Federal Register / Vol. 75, No. 85 / Tuesday, May 4, 2010 / Notices 23773 

(MCHB), which is implementing the 

Combating Autism Act Initiative (CAAI) 

in response to the legislative mandate. 

The purpose of this evaluation is to 

design and implement a three-year 

assessment of the effectiveness of 

MCHB’s activities in meeting the goals 

and objectives of the CAAI, and to 

provide sufficient data to inform MCHB 

and the Congress as to the utility of the 

grant programs funded under the 

Initiative. To address the requirements 

for the Report to Congress, the 

evaluation will focus on short-term 

indicators related to: (1) Increasing 

awareness of ASD and other DD among 

health care providers, other MCH 

professionals and the general public; (2) 

reducing barriers to screening and 

diagnosis; (3) supporting research on 

evidence-based interventions; (4) 

promoting the development of evidencebased guidelines and tested/validated 

intervention tools; and (5) training 

professionals. 

Respondents: Grantees funded by 

HRSA under the CAAI will be the 

respondents for this data collection 

activity. The programs to be evaluated 

are listed below. 

1. Training Programs 

• Leadership Education in 

Neurodevelopmental Disabilities 

(LEND) training programs with thirty 

nine grantees; and 

• Developmental Behavioral 

Pediatrics (DBP) training programs with 

six grantees. 

2. Research Programs 

• Two Autism Intervention Research 

Networks that focus on intervention 

research, guideline development, and 

information dissemination; 

• Five R40 Maternal and Child Health 

(MCH) Autism Intervention Research 

Program grantees that support research 

on evidence-based practices for 

interventions to improve the health and 

well-being of children and adolescents 

with ASD and other DD; and 

• Two R40 MCH Autism Intervention 

Secondary Data Analysis Study (SDAS) 

Program grantees that support research 

on evidence-based practices for 

interventions to improve the health and 

well-being of children and adolescents 

with ASD and other DD, utilizing 

exclusively the analysis of existing 

secondary data. 

3. State Implementation Program Grants 

for Improving Services for Children and 

Youth With Autism Spectrum Disorder 

(ASD) and Other Developmental 

Disabilities (DD) 

• Nine grantees will implement state 

autism plans and develop models for 

improving the system of care for 

children and youth with ASD and other 

DD. 

The data gathered through this 

evaluation will be used to: 

• Evaluate the grantees’ performance 

in achieving the objectives of the CAAI 

during the three year grant period; 

• Assess the short- and intermediateterm impacts of the grant programs on 

children and 

• families affected by ASD and other 

DD; 

• Measure the CAAI outputs and 

outcomes for the Report to Congress; 

and 

• Provide foundation data for future 

measurement of the initiative’s longterm impact. 

The estimated response burden is 

shown in Table 1. 

TABLE 1—ESTIMATED HOUR AND COST BURDEN OF THE DATA COLLECTION

Grant program No. of 

respondents 

Responses 

per 

respondent 

Total responses 

Average 

hours per 

response 

Total hour 

burden Wage rate Total hour cost 

LEND ........................................................ 39 6 234 .75 175.5 $39.36 $6907.68 

DBP .......................................................... 6 6 36 .75 27 39.36 1062.72 

State Implementation Program ................ 9 6 54 .75 40.5 38.22 1547.91 

Research Program ................................... 9 6 54 .75 40.5 39.36 1594.08 

Total .................................................. 63 .................... 378 .................... 283.5 .................... 11,112.39 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent within 30 days of this notice to 

the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov 

or by fax to 202–395–6974. Please direct 

all correspondence to the ‘‘attention of 

the desk officer for HRSA.’’ 

Dated April 28, 2010. 

Sahira Rafiullah, 

Director, Division of Policy and Information 

Coordination. 

[FR Doc. 2010–10450 Filed 5–3–10; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0535] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; ‘‘Real Time’’ 

Surveys of Consumers’ Knowledge, 

Perceptions, and Reported Behavior 

Concerning Foodborne Illness 

Outbreaks or Food Recalls 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by June 3, 

2010. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–NEW and 

title ‘‘‘Real Time’ Surveys of Consumers’ 

Knowledge, Perceptions, and Reported 

Behavior Concerning Foodborne Illness 

Outbreaks or Food Recalls.’’ Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

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23774 Federal Register / Vol. 75, No. 85 / Tuesday, May 4, 2010 / Notices 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

‘‘Real Time’’ Surveys of Consumers’ 

Knowledge, Perceptions, and Reported 

Behavior Concerning Foodborne Illness 

Outbreaks or Food Recalls ( OMB 

Control No. 0910–NEW) 

I. Description 

FDA communicates with consumers 

about food recalls directly, at its own 

Web site, and through various mass 

media channels, such as television and 

newspapers, during a foodborne illness 

outbreak or food recall. In these 

communications, FDA typically 

identifies the implicated food, the 

symptoms of the foodborne illness at 

issue, any subpopulations at elevated 

risk of infection or illness, and 

protective measures individuals can or 

should take. The purpose of these 

communications is to provide 

consumers with information so they can 

protect themselves from potential health 

risks associated with an outbreak or 

food recall. Consumers also get 

information about an outbreak or recall 

from other sources, including other 

Federal and State agencies, industry, 

consumer groups, and the mass media, 

which may or may not relay FDA’s 

public announcements. 

Existing data show that many 

consumers do not take appropriate 

protective actions during a foodborne 

illness outbreak or food recall (Refs. 1 

and 2). For example, 41 percent of U.S. 

consumers say they have never looked 

for any recalled product in their home 

(Ref. 2). Conversely, some consumers 

overreact to the announcement of a 

foodborne illness outbreak or food 

recall. In response to the 2006 fresh, 

bagged spinach recall which followed a 

multistate outbreak of E. coli O157: H7 

infections (Ref. 3), 18 percent of 

consumers said they stopped buying 

other bagged, fresh produce because of 

the spinach recall (Ref. 1). Existing 

research also suggests that many 

consumers may not have correct 

knowledge about products subject to a 

given recall. For example, in a survey 

conducted 2 months after the onset of 

the 2006 spinach recall, one third of 

respondents did not know that, in 

addition to bagged spinach, fresh loose 

spinach was part of the recall, while 22 

percent believed that frozen spinach 

was subject to the recall (it was not) 

(Refs. 1 and 3). In order for FDA to 

protect the public health during 

foodborne illness outbreaks or food 

recalls, the Agency needs timely 

information collected from consumers 

as the events unfold to ensure that 

consumers understand the extent of the 

incident and that they are taking 

appropriate actions. Results from the 

information collection will indicate to 

FDA whether the Agency should adjust 

its communications to help consumers 

react appropriately. 

FDA conducts research and 

educational and public information 

programs relating to food safety under 

its broad statutory authority, set forth in 

section 903(b)(2) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 393 (b)(2), to protect the public 

health by ensuring that foods are ‘‘safe, 

wholesome, sanitary, and properly 

labeled,’’ and in section 903(d)(2)(C) to 

conduct research relating to foods, 

drugs, cosmetics, and devices in 

carrying out the act. 

FDA plans to survey U.S. consumers 

using a Web-based panel of U.S. 

households to collect information on 

consumers’ ‘‘real time’’ knowledge, 

perceptions, beliefs, and self-reported 

behaviors for up to five foodborne 

illness outbreaks or food recalls a year. 

Moreover, because the information 

environment during certain foodborne 

illness outbreaks or food recalls evolves 

as new information emerges, the Agency 

plans to field up to three waves of 

independent surveys per event (i.e., 

outbreak or recall). The surveys will 

query consumers on topics such as: (1) 

The products that are subject to the 

outbreak or recall, (2) the implicated 

pathogens, (3) the food vehicle of the 

outbreak or recall, and (4) how 

consumers can protect themselves. FDA 

plans to conduct the surveys soon after 

the onset of an outbreak or recall and 

whenever the Agency suspects that: (1) 

Messages are not reaching consumers, 

and/or (2) consumers do not understand 

the messages, and/or (3) consumers are 

not taking appropriate actions in 

response to the messaging. Collecting 

information quickly during a foodborne 

illness outbreak or food recall is 

important because erroneous 

perceptions or misinterpreted 

information about an outbreak or recall 

can impede consumer adoption of 

recommended protective behaviors. 

Criteria for selecting a particular 

foodborne illness outbreak or food recall 

for a survey will include a qualitative 

assessment of the salience of some or all 

of the following: The geographical 

dispersion of the event, the number of 

illnesses or deaths associated with it, 

the relative familiarity of the food 

product, the complexity of consumer 

precaution instructions, and the 

presence of national media focus. 

The Agency will use the survey 

results to help adjust its communication 

strategies and messages for foodborne 

illness outbreaks or food recalls, when 

needed. The results will not be used to 

develop population estimates. 

In the Federal Register of November 

18, 2009 (74 FR 59558), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Activity No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses Hours per Response Total Hours 

Screener 30,000 1 30,000 .0055 165 

Pre-test 40 1 40 .167 7 

Survey 15,000 1 15,000 .167 2,505 

Total 2,677 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

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Federal Register / Vol. 75, No. 85 / Tuesday, May 4, 2010 / Notices 23775 

1Public Law 104–180, August 6, 1996, Title VI. 

Effective Medication Guides. 

2 21 CFR part 208. 

3 21 CFR 310.501 and 310.515. 

Approximately 30,000 respondents of 

a Web-based consumer panel will be 

screened (3 waves (independent 

surveys)) for each of 5 incidents; 2,000 

respondents per wave). We estimate that 

it will take a respondent 20 seconds 

(0.0055 hours) to complete the screening 

questions, for a total of 165 hours. We 

will conduct a pre-test of the first survey 

with 40 respondents; we estimate that it 

will take a respondent 10 minutes 

(0.167 hours) to complete the pre-test, 

for a total of 7 hours. Fifteen thousand 

(15,000) respondents will complete the 

surveys (3 waves (independent surveys)) 

for each of 5 incidents; 1,000 

respondents per wave). We estimate that 

it will take a respondent 10 minutes 

(0.167 hours) to complete the survey, for 

a total of 2,505 hours. Thus, the total 

estimated burden is 2,677 hours. FDA’s 

burden estimate is based on prior 

experience with consumer surveys that 

are similar to these. 

II. References 

1. Cuite, C., S. Condry, M. Nucci, et al., 

‘‘Public Response to the Contaminated 

Spinach Recall of 2006,’’ Publication no. RR– 

0107–013, New Brunswick, NJ: Rutgers, the 

State University of New Jersey, Food Policy 

Institute, 2007. 

2. Hallman, W., C. Cuite, N. Hooker, 

‘‘Consumer Responses to Food Recalls: 2009 

National Survey Report,’’ Publication no. RR– 

0109–018, New Brunswick, NJ: Rutgers, the 

State University of New Jersey, Food Policy 

Institute, 2009. 

3. Acheson, D., ‘‘Outbreak of Escherichia 

coli 0157 Infections Associated With Fresh 

Spinach—United States, August-September 

2006,’’ 2007 (http://first.fda.gov/cafdas/ 

documents/Acheson_Spinach_

Outbreak_2006_FDA_pres.ppt). 

Dated: April 28, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10357 Filed 5–3–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0184] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Experimental 

Study of Patient Information 

Prototypes 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments for 

research entitled ‘‘Experimental Study of 

Patient Information Prototypes.’’ This 

study is designed to determine based on 

different prototype testing whether 

consumers are able to comprehend 

serious warnings, directions for use, 

drug indications and uses, 

contraindications, and side effects in the 

material that is presented. 

DATES: Submit written or electronic 

comments on the collection of 

information by July 6, 2010. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Management Programs (HFA–250), Food 

and Drug Administration, 1350 Piccard 

Dr., PI50–400B, Rockville, MD 20850 

301–796–3792, 

Elizabeth.Berbakos@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under the PRA (44 U.S.C. 3501– 

3520), Federal agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined in 

44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 

and includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2) (A)) requires Federal agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Experimental Study of Patient 

Information Prototypes—New 

In order to make informed decisions 

about health care and to use their 

medications correctly, consumers need 

easy access to up-to-date and accurate 

information about the risks, benefits and 

safe use of their prescription drugs. 

Consumers currently receive multiple 

pieces of paper with their prescription 

drugs from the pharmacy, containing 

information that is developed and 

distributed through various sources. 

Written prescription drug information is 

provided through a voluntary effort 

(Consumer Medication Information)1 as 

well as through FDA mandated use of 

Medication Guides2 and Patient Package 

Inserts (PPI).3 Patients describe a wide 

range of experiences and varying 

degrees of satisfaction with information 

currently provided at the time 

medicines are received at the pharmacy. 

In some cases, the written documents 

are difficult to read and understand, 

duplicative and overlapping, 

incomplete or contradictory. FDA has 

held multiple public meetings to solicit 

feedback on providing balanced, 

comprehensive and up-to-date 

prescription drug information to 

consumers. 

Since 1968, FDA regulations have 

required that PPIs written specifically 

for patients be distributed when certain 

prescription drugs or classes of 

prescription drugs are dispensed. PPIs 

are required for estrogens and oral 

contraceptives, are considered part of 

the product labeling, and are to be 

dispensed to the patient with the 

product. In the 1970s, FDA began 

evaluating the general usefulness of 

patient labeling for prescription drugs 

resulting in a series of regulatory steps 

to help ensure the availability of useful 

written consumer information. Other 

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